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Posterior Capsule Opacification Study

NCT ID: NCT00312299

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-01-31

Brief Summary

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First object is to compare square edge PMMA with round edge PMMA IOL where the materials are same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials are different

Detailed Description

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Cataract is the vision impairing disease characterized by gradual, progressive thickening of the lens. Posterior Capsular Opacification (PCO) remains the most frequent long term complication. This is initiated by the migration and proliferation of residual lens epithelial cells from the lens equator in the space between the posterior capsule and intraocular lens (IOL)

The combination of IOL material and a sharp edged design is effective in preventing PCO. Aurolab has developed 360 degree square edge IOL with polymethyl methacrylate (PMMA)

100 bilateral senile cataract patients are going to be recruited. First group of 50 patients will receive square edge PMMA in one eye and round edge PMMA in fellow eye. Another group of 50 patients will receive square edge PMMA in one eye and acrysof in fellow eye. PCO will be assessed during each follow up using EPCO software.

Conditions

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Cataract

Keywords

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Double-Blind Method Clinical Trials, Randomized Lenses, Intraocular Prospective Studies PMMA Visual acuity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1 A - Square edge PMMA IOL

50 patientes will recieve square edge PMMA IOL

Group Type EXPERIMENTAL

Square edge PMMA IOL

Intervention Type DEVICE

Arm 1 A - Square edge PMMA IOL

square Edge PMMA IOL

Intervention Type DEVICE

Square edge PMMA intra ocular lens

1B

In group 1, 50 eyes will receive round edge PMMA IOL

Group Type ACTIVE_COMPARATOR

Round edge PMMA IOL

Intervention Type DEVICE

Round edge PMMA IOL

2A

In group 2, 50 eyes will receive square edge PMMA IOL

Group Type EXPERIMENTAL

Square Edge PMMA IOL

Intervention Type DEVICE

Square Edge PMMA IOL lens

2B

In group 2, 50 eyes will receive acrysof IOL

Group Type ACTIVE_COMPARATOR

Acrysof IOL

Intervention Type DEVICE

Acrysof IOL

Interventions

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Square edge PMMA IOL

Arm 1 A - Square edge PMMA IOL

Intervention Type DEVICE

Round edge PMMA IOL

Round edge PMMA IOL

Intervention Type DEVICE

Acrysof IOL

Acrysof IOL

Intervention Type DEVICE

square Edge PMMA IOL

Square edge PMMA intra ocular lens

Intervention Type DEVICE

Square Edge PMMA IOL

Square Edge PMMA IOL lens

Intervention Type DEVICE

Other Intervention Names

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TrueEdge IOL S3602SQ S3602 SA60AT

Eligibility Criteria

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Inclusion Criteria

* Age 40 to 65 years
* Bilateral senile cataract
* Pupil should be at least 7mm dilated
* Nuclear sclerosis grade I, II and III
* Patient willing for second eye surgery within 3 months

Exclusion Criteria

* Debilitated old patients
* Cardiac and serious illness
* Intraoperative complications including PC rent, Zonular dialysis and Rhexis tear
* Inherent zonular weakness
* Glaucoma patients
* Relative afferent papillary defect (RAPD)
* Shallow anterior chamber
* Pseudoexfoliation
* Traumatic cataract
* Uveitis and complicated cataract
* One eyed patients
* Corneal pathology
* Post segment pathology including diabetic retinopathy
* Dense Posterior subcapsular cataract (PSCC) and Posterior polar cataract (PPC)
* High myopic and hyperopic patient
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurolab

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haripriya Aravind, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

Aravind Eye Hospital, Madurai

Locations

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Aravind Eye Hospital

Madurai, Tamil Nadu, India

Site Status

Countries

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India

Other Identifiers

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2PR1210608

Identifier Type: -

Identifier Source: org_study_id